esophageal squamous cell carcinoma
Conditions
Interventions
Intervention group:Camrelizumab combined with induction chemotherapy of albumin paclitaxel and carboplatin + concurrent chemoradiotherapy
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients should sign a written informed consent form and be able to comply with the follow up and related procedures stipulated in the protocol. 2. The age is >= 18 years old and = 12 weeks. 10. The patients had not received chemotherapy, radiotherapy, surgery, Immunotherapy, or biotherapy related to esophageal cancer previously. 11. Lung function test showed FEV1 > 0.8L. 12. With adequate function of organs and bone marrow, which were defined as follows: 1) Blood test: absolute neutrophil count (ANC) >= 1.5 x 10^9 g/dL, platelet count (PLT) >= 100 x 10^9 / L, hemoglobin (HB) >= 9.0 g/dL. 2) liver function: serum total bilirubin (TBIL) = 50ml/min. 4) The coagulation function is sufficient, which is defined as the international standardized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN;If the subject is receiving anticoagulant therapy, as long as PT is within the range of anticoagulant drugs. 5) The myocardial enzyme spectrum was within the normal range. 13. Female subjects had pregnancy test (serum or urine) within 7 days prior to enrollment. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period and 3 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1. History of other primary malignant tumors, except: 1) complete remission of malignant tumor for at least 2 years before inclusion and no other treatment is required during the study period; 2) non-melanoma skin cancer or malignant freckle mole with adequate treatment and no evidence of disease recurrence; 3) carcinoma in situ with adequate treatment and no evidence of disease recurrence. 2. The pathology was small cell carcinoma, adenocarcinoma or mixed carcinoma. 3. There were active massive bleeding and esophageal fistula in primary esophageal lesion within 2 months. 4. Major surgery was performed within 4 weeks of the start of the study (except for diagnosis) or was expected to be performed during the study period. 5. There is active known autoimmune disease and symptomatic treatment of the disease or before 2 years history (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, need only thyroid hormone replacement therapy for hypothyroidism. Patients with vitiligo or with childhood asthma that is in complete remission and does not require any intervention as adults may be included, whereas patients with asthma requiring medical intervention with bronchodilators may not be included). 6. Clinical symptoms or diseases of the heart that are not well controlled: (1) LVEF (left ventricular ejection fraction) 450ms (male);QTc>470ms (female); 7. Active infection or unexplained fever > 38.5 degrees C during screening and before the first administration (subjects with fever caused by tumor can be enrolled according to the researcher's judgment). 8. A history or evidence of interstitial lung disease or active non-infectious pneumonia is known. 9. Active tuberculosis is known. 10. Congenital or acquired immunodeficiency syndrome (such as HIV infection), active hepatitis B (HBV-DNA >= 104 copies /ml) or Hepatitis C (antibody positive for hepatitis C and HCV RNA positive). 11. Previous treatment with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137 or anti-ctla-4 antibodies, or any other antibodies or drugs specifically targeting T cell co-stimulation or checkpoint pathways. 12. Known allergy to any monoclonal antibody or chemotherapy drug (paclitaxel, carboplatin), preparation or excipients. 13. Corticosteroids (> 10mg/ day prednisone) or other immunosuppressive agents were administered 14 days prior to the first administration of the study drug to achieve immunosuppression.In the absence of active autoimmune disease, corticosteroids at physiological doses (prednisone or its equivalent at 10mg/ day are permitted. 14. Adverse events (i.e., level 1 or baseline) resulting from treatment with an anti-tumor monoclonal antibody (mAb), small-molecule targeted therapy, or prior treatment were not recovered within 4 weeks prior to the first use of the study drug.Note: Except for subjects with grade <= 2 neuropathy or grade <= 2 hair loss, if the subject has undergone major surgery, the toxicity and/or complications from the surgical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year OS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety;OS;PFS;ORR;DCR;DoR;TTDM;Quality of Life;Biomarkers associated with immunotherapy;Imaging examination of esophageal cancer; | — |
Countries
China
Contacts
Public ContactBao Yong
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed